BioRestorative Therapies, Inc. Q2 FY2025 earnings call

• Developmental Programs:
  • BRTX-100: Phase II trial for chronic lumbar disc disease (cLDD) with promising data from 36 subjects, over 74% improvement in function, over 72% reduction in pain by 52 weeks, no serious adverse events; intend to meet with FDA for Type B meeting to accelerate BLA license.
  • ThermoStem: Program for obesity and metabolic disorders using brown fat, building patent portfolio, in discussions for license agreement.
• Financial Position: Ended Q2 with $7.4 million in cash, cash equivalents, and marketable securities, no debt.
• Commercial Opportunities: Advanced discussions with partners on BioCosmeceuticals contract manufacturing.

Second quarter 2025 revenues were $303,000, an increase of 240% compared to $89,000 in the same period last year, primarily from the contract manufacturing agreement on BioCosmeceuticals. The second quarter 2025 loss from operations was $3.3 million vs $2.5 million in 2024. Net loss was $2.7 million or $0.30 per share vs $4 million or $0.50 per share in 2024. The company ended the quarter with $7.4 million in cash, cash equivalents, and marketable securities with no outstanding debt.

• Revenue from BioCosmeceuticals is a growing business, but early to predict quarterly trends; visibility to increase with new hires and back-office preparations.
• Enrollment in BRTX-100 trial is over halfway, optimistic about regulatory pathway and potential Phase III development.

• Uncertainties in license agreements for ThermoStem.
• Volatility in revenue from BioCosmeceuticals due to lumpy nature.
• Dependence on successful clinical trials and FDA approvals.

Q: Could you say anything about the timing for the start of the cCDP trial and the size of that trial?

A: No comment on cervical trial, focus on lumbar trial, encouraged by enrollment growth and aim to drive to Phase III.

Q: On the revenue side with Cosmeceutical driving it, do you think that versus the last couple of quarters that this is pretty much up and up from here? Or is it too lumpy to say that?

A: A little early to say up and up, but growing business with increased visibility from new hires and back-office preparations.

Q: Should we expect the same SG&A expense trend this year like last year, heavy in the first quarter, similar but lighter quarters 2 through 4?

A: Yes, appropriate, with potential cool down in SG&A as enrollment continues and regulatory pathway progresses.

Q: Have there been any new recent interactions with FDA suggesting there may be further support for that expedited pathway?

A: Anecdotally heard positive, but no direct disclosure of FDA designation beyond Fast Track.

Q: With regards to Phase 2, the threshold with FDA is 30% on pain and function, but that's from baseline, correct? So what would you need to show versus placebo?

A: Based on 30% minimum improvement in both pain and function from baseline compared to control group; primary endpoint is safety with no serious adverse events.

Q: Do you have a sense of when we could start to see some unblinded data?

A: Better asked after Type B meeting as it will shape regulatory strategy, want to retain alpha from interim analysis if possible.